Analgesia aNd caNcer recUrrence Lung cAncer Resection

Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection

The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.

Study Overview

• Status: Completed
• Conditions: Analgesia; Thoracic Surgery; Opioid Use, Unspecified; Recurrence Tumor
• Intervention / Treatment: Procedure: Peridural analgesia

• Study Type: Observational
• Enrollment (Actual): 382

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10100
    • AOU Citta della Salute e della Scienza di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Description

Inclusion Criteria:

• Age ≥ 18 yrs
• Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Exclusion Criteria:

• Age<18aa
• Pregnancy
• Day hospital patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PERI group	Procedure: Peridural analgesia; We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.
EV group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative incidence of recurrence and the overall survival	5 years

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Edoardo Ceraolo, MD, AOU Citta della Salute e della Scienza di Torino; Principal Investigator: Giulio L Rosboch, MD, AOU Citta della Salute e della Scienza di Torino; Study Director: Ilaria De Domenici, MD, University of Torino

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; thoracic surgery; Opioid use; Recurrence tumor
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: ANNULAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No